2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation (PART 3A - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies)

Omar Tounekti¹, Sandra Prior², Sarah Wassmer¹, Joshua Xu³, Adrian Wong¹, Xiaodong Fang⁴, Ivo Sonderegger⁵, John Smeraglia⁶, James Huleatt⁷, LiNa Loo⁸, Christopher Beaver⁹, Jason DelCarpini¹⁰, Francis Dessy¹¹, Sandra Diebold², Michele Fiscella¹², Fabio Garofolo¹³, Christine Grimaldi¹⁴, Swati Gupta¹⁵, Victor Hou¹⁰, Chad Irwin¹, Dewal Jani¹⁶, Julie Joseph¹, Warren Kalina¹⁷, Sumit Kar¹⁸, Uma Kavita¹⁹, Yanmei Lu²⁰, Jean-Claude Marshall¹⁰, Christian Mayer²¹, Johanna Mora²², Katrina Nolan²³, Kun Peng²⁴, Nathan Riccitelli²⁵, Ingrid Scully¹⁷, Jessica Seitzer²⁶, Mark Stern²², Meenu Wadhwa², Yuanxin Xu²⁶, Daniela Verthelyi²⁷, Giane Sumner¹⁴, Adrienne Clements-Egan²⁸, Cecil Chen²⁹, Boris Gorovits¹⁴, Albert Torri¹⁴, Daniel Baltrukonis³⁰, George Gunn³¹, Akiko Ishii-Watabe³², Daniel Kramer³³, Robert J Kubiak³⁴, Garrett Mullins³⁵, Luying Pan⁹, Michael A Partridge¹⁴, Johann Poetzl³⁶, Michele Rasamoelisolo³⁷, Federico Riccardi Sirtori³⁸, Susan Richards³⁹, Ola M Saad²⁴, Weiping Shao³⁴, Yuan Song²⁴, Sam Song⁹, Roland F Staack⁴⁰, Bonnie Wu⁴¹, Mohanraj Manangeeswaran²⁷, Seth Thacker²⁷

Affiliations

¹ Health Canada, Ottawa, ON, Canada.
² UK MHRA, London, UK.
³ US FDA, Jefferson, AR, USA.
⁴ AskBio, Research Triangle Park, NC, USA.
⁵ Takeda, Opfikon, Switzerland.
⁶ AstraZeneca, Cambridge, UK.
⁷ Gates Medical Research Institute, Cambridge, MA, USA.
⁸ Vertex, Boston, MA, USA.
⁹ Takeda, Cambridge, MA, USA.
¹⁰ Moderna, Mystic, CT, USA.
¹¹ GlaxoSmithKline, Rixensart, Belgium.
¹² REGENXBIO, Rockville, MD, USA.
¹³ BRI Frontage, Vancouver, BC, Canada.
¹⁴ Regeneron, Tarrytown, NY, USA.
¹⁵ AbbVie, Irvine, CA, USA.
¹⁶ Takeda, San Diego, CA, USA.
¹⁷ Pfizer, Pearl River, NY, USA.
¹⁸ WRIB, Toronto, ON, Canada.
¹⁹ Spark, Philadelphia, Pa, USA.
²⁰ Sangamo, South San Francisco, CA, USA.
²¹ Austria AGES, Vienna, Austria.
²² Bristol Myers Squibb, Lawrenceville, NJ, USA.
²³ Merck, West Point, PA, USA.
²⁴ Genentech, South San Francisco, CA, USA.
²⁵ Navigate, a Novartis Subsidiary, San Diego, CA, USA.
²⁶ Intellia, Cambridge, MA, USA.
²⁷ US FDA, Silver Spring, MD, USA.
²⁸ Larimar, Bala Cynwyd, PA, USA.
²⁹ AstraZeneca, South San Francisco, CA, USA.
³⁰ Pfizer, Groton, CT, USA.
³¹ GlaxoSmithKline, Collegeville, PA, USA.
³² Japan MHLW, Tokyo, Japan.
³³ Sanofi, Frankfurt, Germany.
³⁴ AstraZeneca, Gaithersburg, MD, USA.
³⁵ Eli Lilly and Company, Indianapolis, IN, USA.
³⁶ Sandoz, Oberhaching, Germany.
³⁷ Teva, West Chester, PA, USA.
³⁸ EMD Serono, Ivrea, TO, Italy.
³⁹ Sanofi, Cambridge, MA, USA.
⁴⁰ Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.
⁴¹ Johnson & Johnson Innovative Medicine, Spring House, PA, USA.

PMID: 39862111
PMCID: PMC11863570 (available on 2026-01-25)
DOI: 10.1080/17576180.2024.2439229

2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation (PART 3A - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies)

Omar Tounekti et al. Bioanalysis. 2025 Feb.

. 2025 Feb;17(3):105-149.

doi: 10.1080/17576180.2024.2439229. Epub 2025 Jan 25.

Authors

Affiliations

¹ Health Canada, Ottawa, ON, Canada.
² UK MHRA, London, UK.
³ US FDA, Jefferson, AR, USA.
⁴ AskBio, Research Triangle Park, NC, USA.
⁵ Takeda, Opfikon, Switzerland.
⁶ AstraZeneca, Cambridge, UK.
⁷ Gates Medical Research Institute, Cambridge, MA, USA.
⁸ Vertex, Boston, MA, USA.
⁹ Takeda, Cambridge, MA, USA.
¹⁰ Moderna, Mystic, CT, USA.
¹¹ GlaxoSmithKline, Rixensart, Belgium.
¹² REGENXBIO, Rockville, MD, USA.
¹³ BRI Frontage, Vancouver, BC, Canada.
¹⁴ Regeneron, Tarrytown, NY, USA.
¹⁵ AbbVie, Irvine, CA, USA.
¹⁶ Takeda, San Diego, CA, USA.
¹⁷ Pfizer, Pearl River, NY, USA.
¹⁸ WRIB, Toronto, ON, Canada.
¹⁹ Spark, Philadelphia, Pa, USA.
²⁰ Sangamo, South San Francisco, CA, USA.
²¹ Austria AGES, Vienna, Austria.
²² Bristol Myers Squibb, Lawrenceville, NJ, USA.
²³ Merck, West Point, PA, USA.
²⁴ Genentech, South San Francisco, CA, USA.
²⁵ Navigate, a Novartis Subsidiary, San Diego, CA, USA.
²⁶ Intellia, Cambridge, MA, USA.
²⁷ US FDA, Silver Spring, MD, USA.
²⁸ Larimar, Bala Cynwyd, PA, USA.
²⁹ AstraZeneca, South San Francisco, CA, USA.
³⁰ Pfizer, Groton, CT, USA.
³¹ GlaxoSmithKline, Collegeville, PA, USA.
³² Japan MHLW, Tokyo, Japan.
³³ Sanofi, Frankfurt, Germany.
³⁴ AstraZeneca, Gaithersburg, MD, USA.
³⁵ Eli Lilly and Company, Indianapolis, IN, USA.
³⁶ Sandoz, Oberhaching, Germany.
³⁷ Teva, West Chester, PA, USA.
³⁸ EMD Serono, Ivrea, TO, Italy.
³⁹ Sanofi, Cambridge, MA, USA.
⁴⁰ Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.
⁴¹ Johnson & Johnson Innovative Medicine, Spring House, PA, USA.

PMID: 39862111
PMCID: PMC11863570 (available on 2026-01-25)
DOI: 10.1080/17576180.2024.2439229

Abstract

The 18^th Workshop on Recent Issues in Bioanalysis (18^th WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18^th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.Moreover, in-depth workshops on "IVDR Implementation in EU & Changes for LDT in the US" and on "Harmonization of Vaccine Clinical Assays Validation" were the special features of the 18^th edition.As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and Regulatory Agencies experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues.This 2024 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2024 edition of this comprehensive White Paper has been divided into three parts for editorial reasons.This publication (Part 3) covers in the Part 3A the recommendations on Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity and in Part 3B the Regulatory Inputs on these topics. Part 1 (Mass Spectrometry Assays and Regulated Bioanalysis/BMV) and Part 2 (Biomarkers/BAV, IVD/CDx, LBA and Cell-Based Assays) are published in volume 17 of Bioanalysis, issues 4 and 5 (2025), respectively.

Keywords: WRIB; bioanalysis; biomarkers; cell therapy; gene therapy; immunogenicity; vaccine.

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References

1. Savoie N, Booth BP, Bradley T , et al. The 2nd calibration and validation group workshop on recent issues in Good Laboratory Practice bioanalysis. Bioanalysis 2009. - PubMed
1. Savoie N, Garofolo F, Van Amsterdam P , et al. 2009 White paper on recent issues in regulated bioanalysis from the 3rd calibration and validation group Workshop. bioanalysis. 2009;2(1). - PubMed
1. Savoie N, Garofolo F, Van Amsterdam P , et al. 2010 White paper on Recent Issues in Regulated Bioanalysis & global harmonization of bioanalytical guidance. Bioanalysis. 2010;2(12). - PubMed
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1. Desilva B, Garofolo F, Rocci M , et al. 2012 White paper on recent issues in bioanalysis and alignment of multiple guidelines. Bioanalysis. 2012;4(18). - PubMed

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